A Phase Ib/III Randomized, Multicenter, Global Study of Volrustomig Plus Casdatifan or Volrustomig Monotherapy Versus Nivolumab Plus Ipilimumab as First-line Treatment for Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 9
- Locations
- 3
- Primary Endpoint
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Study Overview
Brief Summary
This is a Phase Ib/III, randomized, multicenter, global study evaluating the efficacy and safety of volrustomig in combination with casdatifan for the first-line (1L) treatment of participants with advanced clear cell renal cell carcinoma (ccRCC).
The Phase III part of the study will no longer be conducted.
Detailed Description
The primary purpose of this study is to measure the efficacy and safety of volrustomig in combination with casdatifan in participants with advanced ccRCC (as 1L treatment).
The study was planned to comprise of 2 parts - Phase Ib and Phase III.
In Phase 1b part of the study, participants are planned to be randomized in a 1:1 ratio to receive either dose 1 or dose 2 of volrustomig in combination with casdatifan.
The Phase III part of the study will no longer be conducted.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed RCC with clear cell component.
- •Advanced/metastatic RCC or recurrent disease that has not previously been treated with systemic therapy in the 1L setting.
- •Karnofsky Performance Status ≥ 70%.
- •Provision of acceptable tumor sample.
- •At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.
Exclusion Criteria
- •History of leptomeningeal disease or spinal cord compression.
- •Symptomatic brain metastases.
- •Medical history of severe chronic obstructive pulmonary disease.
- •Active or prior documented autoimmune or inflammatory disorders.
- •Prior systemic therapy for advanced/metastatic RCC. Note - Other inclusion and exclusion criteria may apply as stated in the protocol.
Arms & Interventions
Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
Intervention: Casdatifan (Drug)
Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
Intervention: Casdatifan (Drug)
Arm 1A (Volrustomig Dose 1 + Casdatifan)
Participants will receive dose 1 of volrustomig in combination with casdatifan.
Intervention: Volrustomig (Drug)
Arm 1B (Volrustomig Dose 2 + Casdatifan)
Participants will receive dose 2 of volrustomig in combination with casdatifan.
Intervention: Volrustomig (Drug)
Outcomes
Primary Outcomes
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Up to Day 90 (+7) post last dose
Number of participants who received at least one dose of study treatment will be assessed.
Secondary Outcomes
No secondary outcomes reported